Medical Device Reporting. Pursuant to governmental medical device ------------------------ reporting regulations (e.g. the FDA's Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), TheraSense is required to report to the applicable agency information that reasonably suggests that a FreeStyle Product may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Each of TheraSense and Disetronic agree to supply to the other any such information promptly after becoming aware of it so that each of TheraSense and Disetronic can comply with governmental reporting requirements. It is understood and agreed that reporting to TheraSense shall be within twenty-four (24) hours to enable TheraSense to comply with FDA reporting requirements. Disetronic agrees to use its best efforts to promptly retrieve and return to TheraSense any individual FreeStyle Product which Disetronic has reported to TheraSense or a governmental agency. In the event that TheraSense is required by any regulatory agency to recall a FreeStyle Product, or if TheraSense or a regulatory authority initiates a FreeStyle Product recall, Disetronic shall cooperate with and assist TheraSense and its Authorized Representative in locating, and retrieving if necessary, recalled FreeStyle Products from Customers. Recalls shall be at Disetronic's cost and expense in the European Territory and at TheraSense's cost and expense in the U.S. Territory. Notwithstanding the foregoing, in the event that a recall is primarily due to a FreeStyle Product manufacturing defect then TheraSense shall provide to Disetronic replacement FreeStyle Product at no charge. Disetronic shall maintain records of sales of -18- Initials ____ ____ *** CONFIDENTIAL TREATMENT REQUESTED FreeStyle Products by lot number and by end user to whom such product was sold or otherwise transferred. Upon TheraSense's request, Disetronic shall provide TheraSense with access to such records in the event of a FreeStyle Product recall or other quality related issue. Disetronic shall be responsible for obtaining all records of its sales to end users in the event of a FreeStyle Product recall or other quality related issue. Disetronic shall make available to TheraSense for inspection Disetronic's process and records for adverse event and ...
Medical Device Reporting. Should Stellartech become aware of any information relating to product function and/or safety that may be reportable to US FDA under 21 CFR Part 803 (Medical Device Reporting) or to a member of the EEA under MDD Vigilance such information shall be reported to Thermage immediately. In Section 7 of the Development and Supply Agreement, Section 7.4 is added to read in its entirety as follows:
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Product, and VTAL shall be primarily responsible for evaluation of any reportable incidents that relate to the VTAL Workstation. Each of R2 and VTAL agree to supply to the other any information relating to such reportable incident promptly after becoming aware of it so that each of R2 and VTAL can comply with governmental reporting requirements.
Medical Device Reporting. The Party that is considered the legal manufacturer shall be responsible for reporting to the relevant Regulatory Agency and/or FDA all Complaints and Adverse Events relating to the Product that are required to be reported under FDA medical device reporting regulations, 21 CFR Part 803, as amended.
Medical Device Reporting. Purchaser shall be responsible to report events in compliance with FDA Medical Device Reporting Regulation set forth in 21 CFR Part 803 and any applicable international regulations. Purchaser agrees to make Medical Device Reports available to Supplier within three (3) days of the initial receipt of any report that reasonably suggests that one of the Products (i) may have caused or contributed to a death or serious injury or (ii) has malfunctioned.
Medical Device Reporting. Stryker Instruments shall be responsible for: · Reviewing all complaints received in order to recognize any complaints which may necessitate filing a Medical Device Report. · Informing SUPPLIER of any case in which a Medical Device Reports is necessary. · Filing the applicable Medical Device Report and furnish a copy to SUPPLIER within the require time frame outlined in 21 CFR 803.20. SUPPLIER shall be responsible for: · Evaluating Stryker Instruments decisions regarding Medical Device Report filing. · Supporting the investigation as needed. · Notifying Stryker Instruments whenever Supplier acquires information that may require a Medical Device Report (MDR) filing.
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or have malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Lung CAD Product. Each of R2 and Vital agree to supply to the other any information relating to such reportable incidents promptly after becoming aware of them so that each of R2 and Vital can comply with governmental reporting requirements.
Medical Device Reporting. The Parties agree to comply with and be responsible for reporting all MDR Reportable Events to each other within [***] business days of becoming aware of same and agree to comply with all procedures established by Distributor, in accordance with all Applicable Laws in connection with the tracking and reporting of MDR Reportable Events. Distributor alone is responsible for investigating and reporting to the FDA all MDR Reportable Events.
Medical Device Reporting. Customer shall be solely responsible for reporting all medical device and malfunction reports as defined in 21 C.F.R. § 820, relating to the Product. To the extent Xxxxxx Group has or receives any information regarding any medical device and malfunction report that may be related to the use of the Product, Xxxxxx Group shall immediately, and in no event later than two (2) business days of receipt by Xxxxxx Group, provide Customer with all such information. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Medical Device Reporting. CLEARSIDE BIOMEDICAL shall have responsibility for and shall process all Medical Device Reports (MDRs) or Incidents received on the Product in accordance with federal and/ or international regulations. GERRESHEIMER is responsible for notifying CLEARSIDE BIOMEDICAL immediately of any MDRs they may receive directly.
